Solid Tumors With FGFR2 Alterations, Adult
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations.
Interventions
DRUG3HP-2827
3HP-2827 will be administered orally once daily in 28-day cycles.
Sponsors
3H (Suzhou) Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol * Men or women, age ≥ 18 years at the time of signing informed consent. * Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor. * ECOG score is 0 or 1. * An expected survival of ≥ 12 weeks. * Evaluable or measurable disease per RECIST v1.1. * Adequate organ function, as measured by laboratory values.
Exclusion criteria
* Active brain metastases. * Have other malignancies within the past 3 years. * The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1. * Clinically significant corneal or retinal disease/keratopathy. * Clinically significant cardiovascular disorders. * Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption. * Known to be allergic to any study drug or any of its excipients. * Assessed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation Stage- incidence of adverse events (AEs) | From baseline up until 28 days after the final dose | — |
| Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) | Days 1-28 of Cycle 1 (a cycle is 28 days) | — |
| Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs | From baseline up until 28 days after the final dose | — |
| Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results | From baseline up until 28 days after the final dose | — |
| Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters | From baseline up until 28 days after the final dose | — |
| Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 | Initiation of study drug until study discontinuation, (up to approximately 24 months) | — |
| Expansion stage -Objective response rate（ORR） | Initiation of study drug until disease progression (up to approximately 36 months) | ORR refers to the percentage of patients with best overall response of confirmed CR or PR from the start of study treatment to patient withdrawal due to PD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) | — |
| Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) | — |
| Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) | — |
| Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) | — |
| Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) | — |
| Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. | Initiation of study drug until study discontinuation, (up to approximately 24 months)) | — |
| Duration of Response (DOR) as assessed by RECIST v1.1 | Up to 45 months | DOR refers to the time period from the first evaluation of confirmed CR or PR (whichever occurs first) to PD or death. |
| Disease control rate (DCR) as assessed by RECIST v1.1 | Up to 45 months | DCR refers to the percentage of patients with best overall response of confirmed CR, PR or SD from the start of study treatment to patient withdrawal due to PD. |
| Progression-free survival (PFS) as assessed by RECIST v1.1 | Up to 45 months | PFS refers to the time between the date of first dose and the first PD or death due to any cause based on the investigator's imaging review results |
| Overall survival (OS) | Up to 48 months | OS refers to the time from the date of first dose to the date of death due to any cause. |
| Dose escalation stage - Objective Response Rate (ORR) | Up to 45 months | ORR refers to the percentage of patients with best overall response of confirmed CR or PR from the start of study treatment to patient withdrawal due to PD. |
| Expansion Stage- incidence of adverse events (AEs) | From baseline up until 28 days after the final dose | — |
| Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs | From baseline up until 28 days after the final dose | — |
| Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results | From baseline up until 28 days after the final dose | — |
| Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters | From baseline up until 28 days after the final dose | — |
| Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors | From baseline up until 28 days after the final dose | — |
Countries
China
Contacts
CONTACTShuchao Wu
Outcome results
None listed